Jury: J&J Never Warned of Transvaginal Mesh Risks

A jury found that Ethicon, a unit of Johnson & Johnson, neglected to appropriately warn about risks related to transvaginal mesh (TVM) implants, while also making fraudulent misrepresentations to a plaintiff.

A New Jersey jury ruled in favor of Linda Gross, 47, a South Dakota nurse, and ordered the device maker to pay $3.35 million to Gross and her husband, said Bloomberg.com. Gross underwent 18 surgeries after being implanted with the Ethicon transvaginal mesh device.

The verdict was delivered on the fifth day of deliberations, said Bloomberg.com, was heard in state court in Atlantic City, and is the first of more than 2,100 lawsuits to go to trial over claims that Ethicon’s Gynecare Prolift injured women. The jury said that Johnson & Johnson never warned Gross’s implanting surgeon of the risks associated with TVM. Not surprisingly, Johnson & Johnson claims the Ethicon Prolift device is safe and effective and that it warned of the risks. “Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” said an attorney for the device maker in closing arguments February 15, according to Bloomberg.com.

The Ethicon Prolift is constructed of a polypropylene mesh inserted through a vaginal incision, Bloomberg.com explained. Last June, Ethicon announced it would no longer sell four types of TVM devices, including the Prolift + M™, TVT Secur, Prolift, and Prosima.

As we’ve explained, transvaginal mesh implants are medical devices approved to treat pelvic organ prolapse (POP), a condition in which weakened pelvic muscles cause organs to slide out of place. The device is also approved to treat stress urinary incontinence (SUI) and is meant to strengthen pelvic walls. Mounting litigation and growing adverse health reports question the devices’ safety and efficacy; many question if TVM devices pose more risks than benefits. TVM has been associated with very serious reactions, and not all are physical.

In the Gross case, Superior Court Judge Carol Higbee is considering allowing Gross’s attorneys to pursue punitive damages, said Bloomberg.com. Should punitive damages be allowed—which are intended to punish the defendant—the amount would be capped under New Jersey law, at five times the compensatory damages. In this case, that capped amount would total $16.75 million. Gross sought $3.38 million for lost earnings, past and future medical expenses, and unspecified damages for pain and suffering, said Bloomberg.com.

As we’ve written, the U.S. Food and Drug Administration (FDA) warned that complications associated with TVM implants are “not rare.” The agency also stated that no clear evidence exists that TVM is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers to conduct post-market studies evaluating the dangers of TVM. According to an agency Safety Communication issued last summer, the most common reported adverse events related to TVM includes: Mesh erosion through the vagina (exposure, extrusion, protrusion); pain; infection; bleeding; pain during sexual intercourse (dyapareunia); organ perforation; and urinary problems.

Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety, which were approved through a fast-track process known as the 510(k). Under the 510(k), a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, the process has drawn increasing criticism.

Gross testified that her life has changed dramatically and adversely since she was implanted with the TVM, that she is in constant pain, that she can no longer sit comfortably, and that she has been prescribed 20 different medicines to help with her pelvic problems, said Bloomberg.com. “Who you see standing here now is not who I was,” Gross told jurors. “I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.” Gross testified that she has undergone more than 400 visits to doctors and physical therapists for treatment, examinations, and testing, which she described as “horrific,” wrote Bloomberg.com. “I am fearful of dying because this pain is so bad,” Gross said.

As we’ve explained, thousands of women were recipients of TVM devices, which have come under increased scrutiny since many recipients of these devices began experiencing complications related to their defects. TVM allegedly has a risk of erosion, in which it travels through the body’s tissues. In some cases, the device can become embedded in inappropriate areas and multiple surgeries are required to remove it. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed.